PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt", the "Company" or the “Group”), an international specialist in clinical diagnostics, provides an update following the launch of its research use only (RUO) test for novel coronavirus (2019-nCoV), which has been developed by its subsidiary Primerdesign as a direct response to the recent outbreak of the respiratory virus in China.
Since the World Health Organization declared the 2019-nCoV outbreak a global emergency on the 30 January 2020, the Company has seen strong demand for its nCoV test, which was launched on 31 January 2020. To date, Primerdesign has received orders for 33,000 tests and requests for quotations for another 32,000 tests from over 30 countries, with a high conversion rate from quotations to orders. The Directors believe the Company is well placed to support the growing global demand for nCoV testing.
The Company is also pleased to announce it is planning to launch a CE-Mark approved nCoV test in the week commencing 17 February. This approval will mean the nCoV test can be used for clinical diagnostic testing, as well as expanding its use within laboratories. The Directors believe that Primerdesign will be one of the first companies to market its test with CE-Mark approval.
In addition, the Company has applied to the US Food and Drug Administration (FDA) for Emergency Use Approval (EUA) of its nCoV test. EUA approval would allow laboratories in the US to use the nCoV test for clinical diagnosis on a temporary basis. The Company is working with the FDA in order to demonstrate the consistency and performance of the Primerdesign test for emergency use.
The Company is also in discussions with various NHS hospitals and Public Health England regarding the nCoV test and it has already sold a limited number of tests to certain hospitals for their validation purposes.
As previously announced, the Primerdesign nCoV test is designed to detect only the 2019 strain of the virus, which the Directors believe differentiates it from a number of current tests which are less specific and could, therefore, react to other related viruses, potentially giving rise to a false diagnosis. The Primerdesign test can generate a result in less than two hours meaning that all samples can be screened quickly, which could help stop the unnecessary spread of this virus. The test is also stable at ambient temperatures, which eliminates the need for cold chain shipping in tropical climates and therefore improves the efficiency of the test and reduces transport costs.
Graham Mullis, Chief Executive Officer of Novacyt commented:
“It is still early days in this public health emergency, however coronavirus has already been reported in 23 countries with more than 28,000 reported infections. As one of the first companies to develop and launch a test to detect the 2019 strain of nCoV, we have received unprecedented interest in our test and anticipate demand continuing to grow. In addition, we look forward to launching our CE-Mark approved nCoV test, which we believe provides laboratories with a fast and reliable nCoV test without the need to carry out their own validation. We continue to support our new and existing customers and are working with the various regulatory authorities to try to make our nCoV test available to as many countries and laboratories as possible to support clinicians in reducing the spread of the disease.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
About Novacyt Group
The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.
For more information please refer to the website: www.novacyt.com